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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K923109
Device Name ADULT CHIN STRAP FOR CT TABLES
Applicant
Cook, Inc.
111 Sandiford Dr.
Stouffville
Ontario L4a 7x5,  CA
Applicant Contact CARL D DICKIE
Correspondent
Cook, Inc.
111 Sandiford Dr.
Stouffville
Ontario L4a 7x5,  CA
Correspondent Contact CARL D DICKIE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/25/1992
Decision Date 09/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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